In children with pneumonia, short course of antibiotics comparable to long course
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A 5-day course of antibiotics was just as effective as the standard 10-day course in treating community-associated pneumonia in nonhospitalized children, according to a study published in JAMA Pediatrics.
Based on the results of the study, Jeffrey M. Pernica, MD, head of the division of pediatric infectious disease at McMaster University in Hamilton, Ontario, and colleagues said guidelines “should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.”
They conducted a two-center, parallel-group, noninferiority randomized clinical trial composed of a single-center pilot study from Dec. 1, 2012, to March 31, 2014, and a follow-up main study from Aug. 1, 2016, to Dec. 31, 2019, in the EDs of McMaster Children’s Hospital and the Children’s Hospital of Eastern Ontario.
In all, 281 participants were included, with a median age of 2.6 years (interquartile range, 1.6-4.9 years). Participants were required to have community-associated pneumonia (CAP) but had to be well enough to be treated as outpatients, the researchers explained.
The authors defined CAP cases as having the following criteria: fever in the 48 hours before presentation; tachypnea, or increased work of breathing on examination; chest radiography findings consistent with CAP; and a primary diagnosis of CAP, per the ED physician.
Pernica and colleagues randomly assigned participants in a 1:1 ratio to high-dose amoxicillin therapy for 5 days, followed by 5 days of a placebo, or high-dose amoxicillin therapy for 5 days, followed by a different formulation of high-dose amoxicillin for an additional 5 days.
The authors defined clinical cure as all of the following: initial improvement during the first 4 days after enrollment; significant improvement in dyspnea and increased work of breathing; no more than one fever spike; and lack of a requirement for additional antibacterials or admission to a hospital.
In the intention-to-treat analysis, 108 of 126 children (85.7%) in the intervention group achieved clinical cure compared with 106 of 126 children (84.1%) in the control group (risk difference [RD] = 0.023; 97.5% confidence limit [CL] –0.061).
In the per-protocol analysis, 101 of 114 participants achieved clinical cure in the intervention group (88.6%) compared with 99 of 109 children (90.8%) in the control group (RD = –0.016; 97.5 CL, –0.087). However, “because the 1-sided 97.5% CL around the risk difference crossed the 7.5% noninferiority margin, a formal conclusion of noninferiority could not be made” in the per-protocol analysis, Pernica and colleagues wrote.
“In a population of previously healthy children diagnosed with CAP in Canadian EDs, outcomes associated with the use of 5 days of high-dose amoxicillin were comparable to those associated with the use of 10 days of high-dose amoxicillin,” the authors wrote. “Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.”
In a related editorial, Sharon V. Tsay, MD, a medical officer in the CDC’s Division of Healthcare Quality Promotion, and colleagues called antibiotics “the double-edged swords we love to yield.” “They save lives, but they also cause harm with adverse drug events and the promotion of antibiotic resistance,” they wrote.
According to Tsay and colleagues, evidence has been growing to support shorter courses of antibiotics in adults for treating conditions such as pneumonia. However, they noted that the evidence for children in this regard is lacking.
Currently, WHO recommends 3 to 5 days of antibiotic therapy for children globally, although guidelines from the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America do not recommend a specific duration of antibiotic therapy for children with CAP, Tsay and colleagues reported.
“This study adds to a growing body of evidence that the optimal duration of antibiotic therapy for CAP is shorter than what is traditionally given,” Tsay and colleagues wrote. “Performing a high-quality trial in the specific target population strengthens the finding that 5 days of antibiotic therapy likely works as well as 10 days for most children with pneumonia.”
References:
Pernica JM, et al. JAMA Pediatr. 2021;doi:10.1001/jamapediatrics.2020.6735.
Tsay SV, et al. JAMA Pediatr. 2021;doi:10.1001/jamapediatrics.2020.6743.
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